Contract Biostatistician - New Jersey

New Contract Opportunity!!
Contract Biostatistician
Global Pharmaceutical
Bedminister New Jersey
12 months ( extend/hire after)

I'm am a specialist recruiter for Biostatisticians and Statistical Programmers for the Pharmaceutical Industry. I can be found here: http://www.linkedin.com/in/pauldai

At the moment I am seeking a Biostatistician to start work with one of my clients (a Global Pharma) in the New Year. Ideally they are looking to identify someone in the next two weeks before the Holidays. So interviews are happening ASAP. APPLY TODAY! Join a major player in the Industry and take your career forward!

Also, REFERRALS WELCOME!

Here's the job spec:

RESPONSIBILITIES:

·Support/participate in the development of clinical program
·Review protocols and CRFs for soundness of trial design
·Write statistical methodology section of the protocol
·Develop statistical analysis plan (SAP), programming specifications, and SAS programing for derived dataset and validate TFLs
·Perform inferential analyses; inputs to the statistical section of the clinical study report and review clinical study report
·Support/participate in project related activities including preparation of BLA submissions and oversee CR0 deliverables for studies contracted out
·Act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. With some supervision and guidance from senior departmental staff, design clinical study and help produce protocol or amendments. Perform relevant sample size calculations
·Perform statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR), and work with the study team to move the CSR through review and approval process
·Provide statistical insight into interpretation and discussion of study results

REQUIREMENTS:

M.S. required in Statistics, Biostatistics, Public Health or related field; PhD recommended

Three (3) years experience in clinical trials including marketing applications (NDA/BLA) submissions, including FDA and EMEA experience

Excellent communication and writing skills

Experience with cancer clinical trials preferred

Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management

Knowledge of EDC and CDISC preferred

Skilled with SAS or S-Plus

Please apply and/or send resumes directly to me ''
Feel free to ask any questions.

Thanks
Paul DaiTo find out more about Real Staffing please visit www.realstaffing.com